MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC

Model Number SYM2515E

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Edema (1820); Fever (1858); Pain (1994); Scar Tissue (2060); Tachycardia (2095); Hernia (2240); Injury (2348); Ascites (2596); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced recurrence, adhesions, and small bowel perforation.Post-operative patient treatment included ventral hernia recurrence requiring placement of sutures and new mesh, abundant adhesions released, excision of previous meshes, small bowel perforation repair, small bowel resection, incisional hernia recurrence requiring placement of new mesh, removal of old mesh due to risk of infection as well as extensive lysis of adhesions.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.Additional information: description of event or problem, other relevant history, explant date, premarket identification, adverse event problem, medical products & therapy dates continuation: (lot# n5b0257urx).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced recurrence, adhesions, fever, tachycardia, and small bowel perforation.Post-operative patient treatment included ventral hernia recurrence requiring placement of sutures and new mesh, abundant adhesions released, excision of previous meshes, small bowel perforation repair, small bowel resection, incisional hernia recurrence requiring placement of new mesh, removal of old mesh due to risk of infection as well as extensive lysis of adhesions.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced recurrence, adhesions, fever, tachycardia, free air in abdomen, fluid accumulation, edema, vascular congestion, chronic serositis, non-adherent mesh, scar tissue, and small bowel perforation.Post-operative patient treatment included revision surgery, abundant adhesions released, excision of previous meshes, small bowel perforation repair, small bowel resection, incisional hernia recurrence requiring placement of new mesh, bilateral myocutaneous release, excision of excess skin, antibiotics, as well as extensive lysis of adhesions.

Manufacturer Narrative

Patient code-c64343 (free air in abdomen, vascular congestion, chronic serositis) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a4, b5, b7, d8, e1(facility name, street 1, city, region, postal code), g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), g4(510k), h6(patient codes), additional code medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced recurrence, adhesions, fever, tachycardia, free air in abdomen, fluid accumulation, edema, vascular congestion, chronic serositis, non-adherent mesh, scar tissue, pain, and small bowel perforation.Post-operative patient treatment included revision surgery, abundant adhesions released, excision of previous meshes, small bowel perforation repair, small bowel resection, incisional hernia recurrence requiring placement of new mesh, bilateral myocutaneous release, excision of excess skin, ct-scan, antibiotics, as well as extensive lysis of adhesions.Relevant tests/laboratory data, including dates (b7): (b)(6) 2015: per op note, ct scan reveals increasing free air in abdomen <(>&<)> fluid accumulation.Suspect gastrointestinal perforation.Surgical pathology report of small bowel segment reveals submucosal edema, vascular congestion, serosal adhesions <(>&<)> acute <(>&<)> chronic serositis.

• Brand Name: SYMBOTEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8783166
• MDR Text Key: 150806140
• Report Number: 9615742-2019-02521
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190474
• UDI-Public: 10884521190474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: SYM2515E
• Device Catalogue Number: SYM2515E
• Device Lot Number: PNK0128X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 06/05/2019; 06/05/2019; 11/23/2022
• Supplement Dates FDA Received: 12/26/2019; 02/07/2020; 11/30/2022
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RELTACK3X10 RELIATACK ARTICULAT RELOAD A.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 96 KG